Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT06411132
Brief Summary:
Primary Objective
\- To assess the proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity.
Secondary Objectives
* To assess corneal sensitivity via Cochet-Bonnet esthesiometer.
* To assess tear secretion via Schirmer I test.
* To assess Ocular Pain Assessment Survey (OPAS) questionnaire results.
Detailed Description:
This observational clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who presented with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity.
A multicenter design allowed for a greater diversity of patient population with Sjögren's dry eye.
The number of sites allowed for quick enrollment and expedited results that helped physicians understand the corneal sensitivity levels in the population of patients with Sjögren's dry eye.
This study design was minimally invasive and might be completed in a single visit provided all qualification criteria were met.
This design reduced the time commitment from patients, thereby reducing barriers for enrollment and participation.
Only one eye (study eye) was analyzed for endpoints; if both eyes qualified for the study, the eye with the worse staining (per National Eye Institute \[NEI\] scale) was the study eye. If staining was equal between eyes, the right eye was the study eye.
Please note that no safety monitoring was captured, as this was an observational and descriptive study, and no study drug was administered. All testing and procedures conducted in this study were performed consistent with clinical practice standards and should not pose any additional risk to patients.
Study:
NCT06411132
Study Brief:
Protocol Section:
NCT06411132